T3 T3ST410Recalls & reported problems
ZimVie US Corp LLC · T3 PRO Non-Platform Switched Tapered Implant 4mm (D) X 10mm (L) · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
Quick summary
This ZimVie T3 PRO tapered dental implant is a screw-shaped root-form implant used to replace a missing tooth. The 33 reports mostly describe implants that had to be taken out because of infection, with pain, swelling, inflammation, and bone loss around the site; one report notes the bone around the implant did not grow in properly. All 33 reports describe injuries, and no deaths were reported. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 34
- Deaths reported
- 0
- Injuries reported
- 34
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 00844868046912), received between Jan 9, 2023 and Jul 27, 2026 — classified as 34 injuries.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem31
- Device Markings/Labelling Problem1
- Failure to Osseointegrate1
- Patient-Device Incompatibility1
Patient problems
- Unspecified Infection24
- Osteolysis14
- Pain9
- Inflammation7
- Swelling/ Edema4
- Erosion2
- Hypersensitivity/Allergic reaction2
- Sinus Perforation2
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
InjuryJul 27, 2026Adverse Event Without Identified Device or Use Problem
It was reported that the implant at tooth site 24 was removed due to infection. The patient developed an infection, presenting with pain, edema, and an abscess. Implant was removed.
Patient problems: Abscess; Swelling/ Edema; Unspecified Infection
MAUDE report 50017911 ↗InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #16 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND INFLAMMATION.
Patient problems: Inflammation; Pain; Unspecified Infection
MAUDE report 25306444 ↗InjuryApr 2, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #12 WAS PLACED WITH GOOD PRIMARY STABILITY (50 N-CM). WHEN IT WAS REMOVED, USUALLY SAVING IMPLANT RESCUE KIT "MEDIUM" INSERT FITS, HOWEVER, THIS IMPLANT NEEDED "WIDE" INSERT BECAUSE THE MEDIUM ONE COULD NO BE ENGAGED. THERE MAY BE STRUCTURAL PROBLEM ON INNER SIDE OF IMPLANT.
Patient problems: Osteolysis
MAUDE report 24769259 ↗InjuryMar 23, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT AN IMPLANT AT TOOTH SITE #26 WAS REMOVED DUE TO AN INFECTION. (B)(6) 2025: IMPLANT IN POSITION 26 WAS PLACED WITHOUT COMPLICATIONS. (B)(6) 2026: A FISTULA WAS NOTED AT THE SITE OF IMPLANT 26; AMOXICILLIN WAS PRESCRIBED. (B)(6) 2026: EXTENSIVE INFLAMMATORY TISSUE OBSERVED; IMPLANT WAS REMOVED. PATIENT SUFFERED FROM ABSCESS AND INFLAMMATION. PROCEDURE WAS COMPLETED WITH CURETTAGE
Patient problems: Fistula; Inflammation; Unspecified Infection
MAUDE report 24660509 ↗InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THE IMPLANT WAS REMOVED DUE TO AN INFECTION AND BONE LOSS AT TOOTH SITE #14. PATIENT SUFFERED PAIN AND SWELLING.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 24578026 ↗InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANTS AT TOOTH SITES #36 AND #37 WERE REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN AND SWELLING.
Patient problems: Pain; Swelling/ Edema; Unspecified Infection
MAUDE report 24562803 ↗InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Pain; Unspecified Infection
MAUDE report 24132673 ↗InjuryJan 21, 2026Adverse Event Without Identified Device or Use Problem
NO ADDITIONAL EVENT INFORMATION RECEIVED AT THE TIME OF THIS REPORT.
Patient problems: Discomfort; Pain; Unspecified Infection
MAUDE report 24132359 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 24083183 ↗InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #46 WAS REMOVED DUE TO PERI-IMPLANTITIS AND LOST OF MOBILITY. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Osteolysis; Pain; Unspecified Infection
MAUDE report 24081230 ↗InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #15 WAS REMOVED DUE TO BONE DEFECT, AND PERI-IMPLANTITIS WITH INFLAMMATION. PATIENT HAD PAIN.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 23692831 ↗InjuryAug 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE DENTAL IMPLANTS LOCATED IN POSITIONS NUMBER #24 & #26 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTED PAIN, INFLAMMATION, AND EDEMA.
Patient problems: Osteolysis; Swelling/ Edema; Unspecified Infection
MAUDE report 22697868 ↗InjuryMay 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR AN EMERGENCY APPOINTMENT IN WHICH THE IMPLANT AT TOOTH SITE #14 WAS REMOVED DUE TO PERI-IMPLANTITIS. SYMPTOMS AS A RESULT OF THE EVENT: PAIN, EDEMA AND INFLAMMATION.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 22115673 ↗InjuryMay 30, 2025Patient-Device Incompatibility; Patient-Device Incompatibility
NO FURTHER EVENT INFORMATION IS AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Hypersensitivity/Allergic reaction
MAUDE report 22113794 ↗InjuryMay 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 22066043 ↗InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION. TOOTH LOCATION UNKNOWN.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 22046199 ↗InjuryMay 19, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT WAS REMOVED DUE TO INFECTION. TOOTH LOCATION UNKNOWN. SYMPTOMS AS A RESULT OF THE EVENT: PAIN.
Patient problems: Pain; Unspecified Infection
MAUDE report 22046131 ↗InjuryMay 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO INFECTION & BONE LOSS. PATIENT PRESENT FOR POST OP VISIT & HAD ABSCESS; RADIOGRAPH SHOWED SEVERE BONE LOSS. REMOVED IMPLANT & GRAFTED WITH PUROS & LPRF. SYMPTOMS AS A RESULT OF THE EVENT: ABSCESS.
Patient problems: Erosion; Osteolysis; Unspecified Infection
MAUDE report 21952261 ↗InjuryMar 28, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #3 WAS REMOVED DUE TO BONE LOSS.
Patient problems: Osteolysis
MAUDE report 21717950 ↗InjuryMar 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #4 WAS REMOVED DUE TO INFECTION.
Patient problems: Unspecified Infection
MAUDE report 21633714 ↗InjuryMar 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #19 WAS REMOVED DUE TO INFECTION. SYMPTOMS AS A RESULT OF THE EVENT: INFLAMMATION.
Patient problems: Inflammation; Unspecified Infection
MAUDE report 21552506 ↗InjuryDec 23, 2024Device Markings/Labelling Problem; Device Markings/Labelling Problem
DOCTOR REPORTED THAT WHEN OPENING THE IMPLANT BLISTER HE NOTICED THAT THE IMPLANT INSIDE THE BLISTER WAS NOT 8.5 BUT 10. PATIENT HAS BEEN SENT HOME. NO IMPLANT PLACED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20999300 ↗InjuryDec 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.
Patient problems: Unspecified Infection
MAUDE report 20975664 ↗InjuryDec 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT THE IMPLANT AT TOOTH SITE #30 WAS REMOVED DUE TO NERVE INJURY. AN INJURY NOTED POST OP DAY ONCE. IMPLANT WAS REMOVED AND NO OTHER IMPLANT WAS PLACED TO COMPLETE THE PROCEDURE. NO ADDITIONAL APPOINTMENT REQUIRED. SYMPTOMS AS A RESULT OF THE EVENT: PARESTHESIA.
Patient problems: Nerve Damage; Paresthesia
MAUDE report 20932566 ↗InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE DOCTOR REPORTS THAT THE DENTAL IMPLANT LOCATED IN DENTAL POSITION NUMBER 47 FAILED DUE TO PERI-IMPLANTITIS. THE DOCTOR REPORTS IN THE PER THAT THE PROCEDURE WAS NOT CONCLUDED BY PLACING ANOTHER IMPLANT. BONE TYPE: IV. THE DOCTOR REPORTED : INFLAMMATION + ABSCESS.
Patient problems: Inflammation; Osteolysis; Unspecified Infection
MAUDE report 19816462 ↗
Other Implant, Endosseous, Root-Form devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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